Journal
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Volume 55, Issue 18, Pages 1915-1922Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jacc.2010.01.027
Keywords
aerosol; inhalation therapy; prostacyclin; pulmonary arterial hypertension; pulmonary heart disease; pulmonary vascular disease; treprostinil sodium
Categories
Funding
- United Therapeutics Corporation
- Actelion Pharmaceuticals
- Encysive
- Pfizer
- United Therapeutics Corp. [US020080200449A1, WO002007134292A3]
- Gilead Sciences
- Lung Rx, Inc.
- Lilly
- GlaxoSmithKline
- Myogen
- Novartis
- Unither
- Deutsche Forschungsgemeinschaft
- Osterreichische Nationalbank
- European Union
- Schering AG
Ask authors/readers for more resources
Objectives This study assessed the efficacy and safety of inhaled treprostinil in pulmonary arterial hypertension (PAH) patients receiving therapy with either bosentan or sildenafil. Background There is no cure for PAH, despite effective treatments, and outcomes remain suboptimal. The addition of inhaled treprostinil, a long-acting prostacyclin analog, might be a safe and effective treatment addition to other PAH-specific oral therapies. Methods Two hundred thirty-five PAH patients with New York Heart Association (NYHA) functional class III (98%) or IV symptoms and a 6-min walk distance (6MWD) of 200 to 450 m while treated with bosentan (70%) or sildenafil were randomized to inhaled treprostinil (up to 54 mu g) or inhaled placebo 4 times daily. The primary end point was peak 6MWD at 12 weeks. Secondary end points included time to clinical worsening, Borg Dyspnea Score, NYHA functional class, 12-week trough 6MWD, 6-week peak 6MWD, quality of life, and PAH signs and symptoms. The biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP) was assessed. Results Twenty-three patients withdrew from the study prematurely (13 treprostinil, 10 placebo). The Hodges-Lehmann between-treatment median difference in change from baseline in peak 6MWD was 19 m at week 6 (p = 0.0001) and 20 m at week 12 (p = 0.0004). Hodges-Lehmann between-treatment median difference in change from baseline in trough 6MWD at week 12 was 14 m (p = 0.0066). Quality of life measures and NT-proBNP improved on active therapy. There were no improvements in other secondary end points, including time to clinical worsening, Borg Dyspnea Score, NYHA functional class, and PAH signs and symptoms. Inhaled treprostinil was safe and well-tolerated. Conclusions This trial demonstrates that, among PAH patients who remain symptomatic on bosentan or sildenafil, inhaled treprostinil improves exercise capacity and quality of life and is safe and well-tolerated. (TRIUMPH I: Double Blind Placebo Controlled Clinical Investigation Into the Efficacy and Tolerability of Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension; NCT00147199) (J Am Coll Cardiol 2010;55:1915-22) (C) 2010 by the American College of Cardiology Foundation
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available